New injection aims to retrain immune cells to fight arthritis
NCT ID NCT07349420
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new drug called EF-M2 (Immutalon) in 48 adults with moderate-to-severe rheumatoid arthritis. The drug is designed to shift immune cells from a pro-inflammatory to an anti-inflammatory state. Participants received injections for 4 weeks, and researchers monitored safety and signs of immune changes. The goal is to see if this approach can control disease without needing lifelong medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EF-M2 (Immutalon), a drug injected under the skin to shift immune cells toward an anti-inflammatory state
- What this could lead to
- If it works, this could point toward a new way to control rheumatoid arthritis by calming overactive immune cells without long-term side effects.
- What could go wrong
- This is a very early, small trial (48 people) focused on safety, not proof of effectiveness. The drug may not work or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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48 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 70 years. * Diagnosis of rheumatoid arthritis according to the 2010 American College of - Rheumatology and European Alliance of Associations for Rheumatology classification criteria for at least 6 months. * Moderate-to-severe active disease, defined as: * Disease Activity Score in 28 joints using C-reactive protein at least 3.2 and not more than 6.0; and * At least 6 tender joints and at least 6 swollen joints based on the 28-joint count. * Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (for example, methotrexate or leflunomide); and either: * No prior biologic or targeted synthetic disease-modifying antirheumatic drug therapy; or * No more than one prior line of biologic or targeted synthetic disease-modifying antirheumatic drug therapy, discontinued at least 12 weeks before screening. * Stable background therapy: * Conventional synthetic disease-modifying antirheumatic drug at a stable dose for at least 8 weeks; and * Glucocorticoids at a dose not exceeding 10 milligrams per day of prednisone (or equivalent) at a stable dose for at least 4 weeks; and * Nonsteroidal anti-inflammatory drugs and/or analgesics on a stable regimen for at least 2 weeks. * Willingness and ability to comply with study visits, biospecimen collection, and contraception requirements (for women and men). Exclusion Criteria: * Current severe infection; active or latent tuberculosis without completed preventive therapy. * Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus infection with high viral load. * Active malignancy or history of malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or skin. * History of severe opportunistic infections. * Uncontrolled cardiovascular disease (including New York Heart Association class III or IV heart failure, acute coronary syndrome within the past 6 months, or uncontrolled arterial hypertension), decompensated diabetes mellitus, or severe liver or kidney disease. * Pregnancy, breastfeeding, or planning pregnancy within 6 months. * Prior treatment with cellular therapies, chimeric antigen receptor T-cell therapy, or profound immunosuppressive therapies with incomplete immune reconstitution. * Any condition that, in the investigator's opinion, increases the risk of study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for New Medical Technologies
Novosibirsk, Novosibirsk Oblast, 630090, Russia
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Other studies related to the condition(s) this trial covers.
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